In his memoirs, "Enduring Memories", self-published in 2003, John Walker-Smith, former professor of paediatric gastroenterology at the Royal Free hospital and medical school, London, explained how he had worked on a "high risk" research project in the 1990s with now-disgraced former doctor Andrew Wakefield, which attempted to link MMR with autism and bowel disease.
Walker-Smith claimed to have approval from the hospital's ethics committee and, with another doctor, confirmed this when challenged in February 2004 by a Sunday Times investigation by me. Two now-retracted papers made the same claim: that he was running authorised medical research.
But when in 2007 the UK's General Medical Council proved the given story false, and arraigned Walker-Smith for misconduct, he sat mute for many months while the council's lawyers set out its proof, and then, after the prosecution's case closed, he announced a new story: that he was only involved in clinical care, and that the approved research project never even happened.
In 2012 Walker-Smith brought out a new edition of his memoirs, striking his previous account and retrospectively altering his stated intent of 1996.
Research: John Walker-Smith, Enduring Memories, 2003
"Now Andy wakefield was keen to organize a research study of this group of children. Many parents were pleading for this to be done, some even demanding it. Indeed some years later an angry group of parents ambushed me in a hostile way, because we were not going ahead with more research. The centre piece of the research however would be first a study to see if there was significant bowel inflammation in these children which could be treated. A secondary but important question would be whether measles virus, especially the vaccine virus strain, was present in any inflamed tissue which might be found. This research could only be contemplated if my endoscopic colleagues Simon Murch and Mike Thomson were prepared to undertake ileo-colonoscopy in these children and believed that it was important to do so. They agreed. Andy Wakefield sought evidence of measles virus ultimately with John O’Leary of Dublin using sophisticated molecular techniques. Also it was essential that a child psychiatrist be involved to vet the accuracy of the diagnosis of autism. Mark Berlowitz enthusiastically agreed. My own role in all this was permissive as Andy Wakefield was the research leader, the conductor of the orchestra, a classical role in research for a gastroenterologist. A team was assembled, an ethical committee application was obtained and a pilot study went ahead."
Clinical care: John Walker-Smith, Enduring Memories, 2012
"From early 1996 Andy Wakefield was keen to develop a research study of this group of children, whose parents had contacted him by telephone. Many parents were pleading for this to be done, some even demanding it. Indeed some years later an angry group of parents ambushed me in a hostile way, because we were not going ahead with more research, albeit of a different nature. The centre piece of the research per se would be to determine whether measles virus, especially the vaccine virus strain, was present in any inflamed tissue which might be found in these children and to investigate a pathogenetic hypothesis. This research could only be contemplated as a by-product of routine investigation. If I considered inflammatory bowel disease was a likely or possible diagnosis, then I would recommend diagnostic ileo-colonoscopy with multiple biopsies. Provided my endoscopic colleagues Simon Murch and Mike Thomson agreed with my recommendation and were themselves prepared to undertake clinically-indicated ileocolonoscopy in these children, then it would be possible for Andy’s research to go ahead. After discussions between the three of us we agreed the way forward was to discuss a research project with Andy Wakefield.
"In the meantime I began to see children by clinical need. Any research would be a by-product of clinically indicated investigations. I already had ethical approval for two extra research biopsies to be taken in all children who had colonoscopy provided there was parental approval.
"So Andy in his laboratory, with immunohistochemistry would seek evidence of measles virus as the first step to develop his research hypothesis. Although later on John O’Leary of Dublin would take over this work using more sophisticated molecular techniques.
"In planning such research it was essential that a child psychiatrist be involved to vet the accurancy of any diagnosis of autistic spectrum disorder, so that any laboratory finding was placed within an accurate clinical context. Mark Berelowitz enthusiastically agreed. A team was assembled, an ethical committee application was developed to investigate an hypothesis and was submitted by Andy Wakefield but based upon our clinically indicated diagnostic approach. The Ethical Committee approved the application but in the event the study was not implemented. More modest studies based upon ethically approved research biopsies went ahead."
Other extraordinary features of Walker-Smith's revised account in 2012 include suggestions by him that his lengthy arraignment by the GMC was somehow unfair and inexplicable, when, in reality, it was largely driven by an agonizingly protracted attempt by him to retrospectively diagnose clinical indications for an extraordinary battery of invasive tests on 12 vulnerable children (including children he had never seen before the tests were performed) set out in Wakefield's research. He also claims that perhaps some "deus ex machina" lay behind the case, when he knew that it was previous untrue assertions of ethical approval that led to many of the charges against him.
Indeed, in a 2012 English High Court judgment, Mr Justice Mitting endorsed the findings of my own investigation which discovered that a claim, published in the Lancet in February 1998 by Wakefield, Walker-Smith and others that "Investigations were approved by the Ethical Practices Committee of the Royal Free Hospital NHS Trust, and parents gave informed consent" was false.
As Mitting ruled: "This statement was untrue and should not have been included in the paper."
Ethical approval is a vital issue for patient protection, especially when children or mentally incapacitated subjects are involved, as was the case in Wakefield's and Walker-Smith's research. Criteria exist to determine when it is needed.
The final sentence in Walker-Smith's 2012 account, on the right above, is grossly misleading. His team had permission only to take two biopsy samples from children for research purposes, but no permission had been granted to perform any research procedure on these or on any other samples, which would require separate applications to the hospital's ethics committee.
It should be noted that Andrew Wakefield did not have ethical approval to receive biopsies from clinicians, research on biopsies, publish findings or do anything whatsoever with regard to the children enrolled in the above research project, for which he had been commissioned and funded by the UK legal aid board. He was erased from the UK medical register in 2010, and his lawyers did not recommend any appeal against the decision.